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Medtronic Sterile Pack A³ Drape PK 1

by Quantum OPS Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860014655944 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Medtronic
Generic Name
Medical equipment/instrument drape, single-use
Model / Ref / Catalog
Sterile Pack A³ Drape PK 1, 81800031
Primary DI / UDI-DI
00860014655944
FDA Product Code
BTX
GMDN Term
Medical equipment/instrument drape, single-use
Device Class
Class I
Regulation Number
878.3910
GUDID distribution status
In Commercial Distribution

Other devices from Quantum OPS Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No